XMRV testing: The REDLABS, trading as VIP Dx, WPI connection

[barbc56]

Mula, post: 291184, member: 4265"s-A pathogen test is interpreted by the laboratory who perform the testing.

As far as I know the laboratory usually gives the values of the tests plus norms but the bottom line interpreter is the physician as he/she would hopefully look at the test taking into account such factors as the patient's history, diagnosis plus other lab tests.

Are you deflecting responsibility of individuals such as Dr. Mikovits, who supposedly kept asking if the the XMRV test was valid but failed to go further than this to disclose any irregularities?

One might hypothesize this as a cover up or possibly even a conspiracy, to keep her employment. Of course, I am only speculating here as I don't have enough facts to make this a definitive statement.
Barb C.:>)


ETA Here's an example of the above. Even though my ferretin level is within the low normal paramaters, the count needs to be at a higher level because I have RLS or Restless Legs Syndrome. If my doctor had not known this, I might not have been referred to a hematologist nor received the needed treatment which in my case was an iron infusion.

 

[ukxmrv]

Barb, Not sure why you would bring up your ferritin level test here to try and argue with Mula's post. Totally different.

The VIP dx test results were discussed in much earlier threads. No physican "interpretation" was needed. It was a specific yes/no test.

 

[barbc56]

Barb, Not sure why you would bring up your ferritin level test here to try and argue with Mula's post. Totally different.

The VIP dx test results were discussed in much earlier threads. No physican "interpretation" was needed. It was a specific yes/no test.

As in yes it's invalid or no it's not valid?

Barb C.:>)

 

[ukxmrv]

Sorry Barb, don't get you. Two countries divided by a common language etc..

Why would you think that the VIP dx XMRV test had a reference range and needed interpretation by a physician?

 

[barbc56]

Sorry Barb, don't get you. Two countries divided by a common language etc..

Why would you think that the VIP dx XMRV test had a reference range and needed interpretation by a physician?

I was answering Mura's statement that only the labratories interpret test results. My response reflected this statement.

Even if a test is a yes or no, as I stated above, it still needs to be interpreted by a physician who is knowledgeable about the patient's history and hopefully most physicians by now know that science is saying the test is completely worthless.
Barb C.:>)

 

[Firestormm]

Pretty sure we covered this above. VIPdx stated that a physician was responsible for interpretation of the results.

 

[In Vitro Infidelium]

Dr Wright was subject to a hearing for having blood tested at an facility not licensed for clinical laboratory testing. Redlabs (Vipdx) was given a CLIA certificate for clinical laboratory testing. I have given the relevant information in my previous response. http://www.nhsla.com/Claims/

The full documents related to the Wright case appear not be online at present and what was previously available made it clear that the issue was not merely some ‘technical’ breach of a licensed/not licensed regulatory standard. It is well established that UK doctors are in breach of professional standards in ordering tests which have no benefit to the patient - a speculative (lacking clinical validation) test such as that offered by VIPdx could never have stood a test of utility. Any UK doctor ordering such a test would have a case to answer under Fitness to Practice regulations. There could be no NHS liability in such a case because there is no provision under the NHS that would allow ordering of clinically unvalidated tests – an exception might be ifsomehow it could be shown that failings in NHS oversight allowed a doctor in private practice to operate outside of professional standards, but really that’s a profoundly attenuated line of argument and could only apply in very rare circumstances.

Why do you deflect from responsibilities of Redlabs and the licensor, WPI, in having marketed tests to patients?

I don’t think anything I’ve written about the WPI or Redlabs since January 2011 (The dubious positions taken by the WPI – marketing of XMRV tests to desperate CFS sufferers before any test validation has been achieved, Saints and demons in the Cult of The Chronically Fatigued ) has deflected due responsibility from any entity or person. I do recall endless angry defences of the WPI, Redlabs, the Whittemores, Mikovits, Lombardi et al from many people who posted on PR and other forums.

What I have throughout the last 20 months consistently sought to do is set out the situation in such a way that history need not repeat itself, that IMO requires a forensic demonstration of just who was responsible, where and how – not so that they may be pilloried or claimed against, but rather so the processes involved will be obvious in any future comparable situation (put bluntly it’s an appeal to: “let’s not ****up like that again”).
Far from deflecting responsibility, the examination of the UK situation allows focus on what otherwise would be an ambiguity. VIPdx’s claimed defence against responsibility for mis-selling was that all orders for tests were only accepted from a physician and that interpretation was a physician responsibility, original statement not online but see: VIPdx Statement from Vince Lombardi re: Testing

In the US, this leaves the issue of mis-selling solely between the ordering physician/patient relationship where there is apparently no imitation other than caveat emptor when test acquisition has been agreed, the physician acting merely as a purchasing agent. This is not the case in the UK where the professional standard is such that the physician has overarching responsibility - this in turn means that it is possible for a UK patient who paid for a VIPdx test, to expose the nature of the mis-selling. Such a patient was either professionally advised by a UK doctor whose conduct in ordering a VIPdx test would be in question and the issue may therefore be tested via a complaint against that doctor, or VIPdx can be shown to have supplied tests directly to patients in which case its statement about physician ordering is false, something that might be tested legally against the owners of the business (Seeno family or their ‘agent’ H.Whittemore ?), or a third option was in play, that is that UK patients were using non UK based physicians who were offering a no responsibility ‘sign off’ service.

In reality patients who purchased tests have shown themselves to be very reluctant to publicly establish proper responsibility, the UK based doctors involved in ordering the tests remain anonymous, no one has been prepared to name any non UK doctor offering a ‘sign off’ deal, and no one has been prepared to publish documentation of tests being supplied to UK residents without VIPdx being given a physician contact. These details must be readily available and would yield clear routes of legal responsibility, I think it is a huge shame that patients are shielding rotten practice because it allows that others will be exploited in the future.
IVI

 

[maryb]

Surely it doesn't matter what VIPdx stated, I am an ME patient I do not understand what positive and negative mean I need a physician to tell me
The statement made by labs about a physician interpreting the results of tests is standard and made just to cover themselves legally. Don't think anyone need one in this case.

 

[In Vitro Infidelium]

The VIP dx test results were discussed in much earlier threads. No physican "interpretation" was needed. It was a specific yes/no test.

So what did being positive (or indeed negative) for XMRV mean ?

Whether or not the tests were absolute is only a minor point - the meaning of the test would (if there was actual medical value) require expert consideration of what specific results meant to the patient. In the UK where the professional standard is unequivical, the results of a test which had clinical value would require interpretation and advice/treatment from the ordering doctor or referal by the ordering doctor to a specialist service for interpretation and advice/treatment. If the test was of no clinical value, all UK doctors would be constrained from ordering the thing in the first place. Where a test was provided as part of ethical medical research, and the test results were to be provided to participants, interpretation and advice should have come from an independent expert assigned by the researchers for such a purpose.

IVI

 

[ukxmrv]

IVI, if you missed out on the earlier long dicussions we had on the XMRV tests from VIP dx then I can only point you back a couple of years and suggest that you search and find them. There is no point going over and over the same things because new people join these groups and take an interest in what happened previously.

 

[ukxmrv]

Barb, what is it about the VIP dx test result that you would need to be interpreted?

It's not clear what would be your problem with the test results and why you think that they would look like your ferritin test (and I am assuming that you know what a VIP dx test result would look like or I don't understand why you would comment here to Mula in that way)

and there are older long threads on what the tests results looked like if you missed that whole conversation back when people here were having the tests and getting the results

 

[In Vitro Infidelium]

IVI, if you missed out on the earlier long dicussions we had on the XMRV tests from VIP dx then I can only point you back a couple of years and suggest that you search and find them. There is no point going over and over the same things because new people join these groups and take an interest in what happened previously.

That is an absurd proposition - it suggests that those who discussed things 'previously' have some exceptional insight - in the case of XMRV that 'insight' was in many cases patently lacking. This thread was started precisely on the basis of 'going back' - unfortunately the historic analysis provided in OP is partial at best, rather like much of the misdirected discussions that sit in the old threads of this forum. If there had been wider acceptance of the critical perspective offered by a number of us - going back several years - then there would likely not now be the high levels of confusion that has spread about the whole debacle.

IVI

 

[jace]

I'm not confused.

• VIP Dx were under the REDLABS USA umbrella
• REDLABS was owned and run by Harvey Whittemore
• VIP Dx offered tests for XMRV to patients
• Patients were aware the tests was experimental
• Mikovits tried to ascertain internally to the WPI whether the tests were the same ones used in Lombardi et al 2009
• When the WPI got fed up with her questioning they sacked her and gagged her
• Forums have search engines
• New members can use them to catch up with what's been said before on a subject they're interested in

 

[In Vitro Infidelium]

I'm not confused.
VIP Dx were under the REDLABS USA umbrella
REDLABS was owned and run by Harvey Whittemore

VIPdx was merely the trading name of Redlabs. Redlabs was (as of 2005) part of the Wingfield Nevada Group, which was initially owned in partnership between Harvey Whittemore and Thomas Seeno , and (according to this document ) by the time that the XMRV tests were being marketed, WNG was wholly in the ownership of Thomas Seeno and two of his relatives. Whittemore appears to have continued in a mangement role after ceding ownership to the Seenos.

VIP Dx offered tests for XMRV to patients
Patients were aware the tests was experimental

Some evidence of what patients were aware of (or could have been aware of ) would be useful - for example did VIPdx publish a rider. And if there was such a rider - surely that makes the post that started this thread wholly redundant, given that a core argument of the posted article is that there is a question of whether or not the VIPdx tests were clinically validated - if the tests were experimental how could they have been clinically validated - both points can not be true. Further, if the tests were known to be experimental, how could VIPdx have received orders for the tests from UK doctors, given that ordering such tests would be of no clinical value to patients ?

Mikovits tried to ascertain internally to the WPI whether the tests were the same ones used in Lombardi et al 2009 When the WPI got fed up with her questioning they sacked her and gagged her

According to Mikovits, that is what happened, some confirmatory evidence would be useful. But the point is anyway irrelevant to the question of clinical validation (which is where this thread starts), clinical validation could never have been achieved without reproducibility of the Lombardi et 2009 results being demonstrated in numerous replication studies. No replication, no clinical validation.

Forums have search engines
New members can use them to catch up with what's been said before on a subject they're interested in

This assumes new members have the slightest interest in flawed arguments from the past. Jace I can't avoid posing this question to you directly - you posted an article at the top of this thread which appears to aim at inquiry into events that have happened in the past - is it really your contention that this article is supposed to be taken at face value, and that anyone who might have questions about the events, is supposed to use old forum postings as an authoritative reference ? Quite honestly despite your protestation to the contrary, you appear very confused, and seem to be spreading that confusion with your postings, would you therefore please at least make it plain which of the followingyou believe is correct and on what evidence you base your belief:

1. Patients purchased VIPdx XMRV tests directly from VIPdx in the full knowledge the tests were experimental.

2. Physicians ordered VIPdx XMRV tests in full knowledge that the tests were of no clinical value, and that their patients were aware that the tests were experimental.

3. Physicians ordered VIPdx XMRV tests in the belief that the test were of clinical value, and that on receiving results of the tests the ordering physicians advised their tested patients on the relevence, signficance and treatment optionsthat followed from having either a negative or postive test for XMRV.

IVI

 

[Mula]

Not that this is of consideration for liability, but the document from the Whittemore v Wingfield civil suit doesn't mention who the current owners of Redlabs are. Only 50% was sold in 2004.

Liability for a test belongs to the laboratory selling the test and those who control the company. Redlabs/vipdx is under the control of Harvey Whittemore. In law he and the laboratory director are responsible for the objective accuracy of the tests as liability belongs to the company and the licensor for monitoring that their licensed tests are as advertised. They are legally culpable if the clinical sensitivity and specificity of the xmrv tests was not established and the tests do not accurately reflect the true status of the patient as far as the presence or absence of xmrv are concerned. No doctor has to interpret these yes or no test. They are not expected to go to the laboratory who is the provider of the test and perform clinical validation assessment. Other papers in this field have not used a clinician to perform a speculative interpretation for those yes or no tests.

Dr Mikovits would have no involvement in commercial testing or licensing, her tests are those in the research study and don't pick up VP62 xmrv env sequences.

 

[Mula]

I am linking to several articles on previous prosecutions of laboratories as it is unfortunate that some are trying to convince others that laboratories are not culpable.

Clinical Pathology Laboratory Manager Is Sued for Manufacturing a Fake Lab Test Report for a Sexually-Transmitted Disease

Certainly this unusual episode provides a real case study of the different ways that an employee can breach patient privacy and involve the medical laboratory in expensive civil litigation and possibly even criminal prosecution. Plaintiff Jane Doe’s civil suit includes these seven charges against Sackmann and Quest Diagnostics:

1. Intentional Infliction of Emotional Distress (Sackmann)
2. Negligent Infliction of Emotional Distress (Quest Diagnostics)
3. Breach of Fiduciary Duty (Quest Diagnostics)—Reckless Indifference
4. Intrusion Upon the Seclusion of Another (Sackmann)
5. Public Disclosure of Private Facts (Sackmann)
6. Intrusion Upon the Seclusion of Another (Quest Diagnostics)
7. Public Disclosure of Private Facts (Quest Diagnostics)

http://www.darkdaily.com/clinical-p...ort-for-a-sexually-transmitted-disease-092910

Did Millennium Laboratories improperly induce physicians? Ameritox thinks so.

http://pathologyblawg.com/2012/03/2...roperly-induce-physicians-ameritox-thinks-so/

Andrea Newton sued a clinical laboratory, a medical review officer, and the review officer's employer, alleging negligent performance of a drug test mandated by Newton's employer. Newton claims that she lost her job because the defendants negligently performed the drug test, and then notified her employer of a positive result.

http://www.gpo.gov/fdsys/pkg/USCOURTS-ca8-07-01111/pdf/USCOURTS-ca8-07-01111-0.pdf

In the first link indictment 2 and 3 would apply to Redlabs and Annette Whittemore should the xmrv tests be shown to be clinically unvalidated. A class action could be launched to have everyone's money returned should that scenario arise, plus they could seek punative damages because in that scenario it would be willful fraud.

 

[ukxmrv]

Sorry IVI, I am not trying to offend you. It's just that the whole topic of the VIP dx tests and what they meant were pretty much thrashed out as a group at the time people were having them done. I don't have anything new to add to this.

At the time I said they I felt they were experimental. Patients who actually made the tests and posted them here seemed to think that they were experimental. Nothing has changed for me since then.

It's unfair to brush off patients experiences as "flawed arguments" just because other people don't agree with you. As I understand it you have not seen a physician for a VIP dx test, seen any of the documentation for private testing or their UK trial?

Maybe you could start a poll and ask people who had the tests what they through they were and what they were told if you want further information.

It seems that you are not aware that UK doctors are on a daily basis ordering experimental tests for patients from abroad. This happens in my experience in other areas not related to ME. When I was treated for another condition I belonged to other forums. The same tests are still being used. These are private doctors but in one case that springs to mind the doctor also has an NHS practise. The private patients are offered the experimental tests and not the NHS ones.

Maybe this is new to you? What I am hearing is that you missed the threads when people were having the test and all the discussions around that plus you also seem to lack experience with the way private doctors are ordering tests for their patients in the UK and in the USA?

 

[jace]

I said:
"Forums have search engines. New members can use them to catch up with what's been said before on a subject they're interested in"

IVI stated

"This assumes new members have the slightest interest in flawed arguments from the past."

Then why spend so much time on this thread, which is mainly about a past situation that many of us have lived through?

would you therefore please at least make it plain which of the followingyou believe is correct and on what evidence you base your belief:

As I said, patients were aware the tests were experimental. As for evidence, use the search engine here.

 

[Firestormm]

I am linking to several articles on previous prosecutions of laboratories as it is unfortunate that some are trying to convince others that laboratories are not culpable....

Mula we were not avoided the discussion about VIPdx having some liability in any of this debacle; the conversation was about the involvement of physicians in the process particularly those in the UK (although this was at least hypothetical pending notification that a patient in the UK had actually engaged with their GP about said tests).

 

[In Vitro Infidelium]

Mula we were not avoided the discussion about VIPdx having some liability in any of this debacle; the conversation was about the involvement of physicians in the process particularly those in the UK (although this was at least hypothetical pending notification that a patient in the UK had actually engaged with their GP about said tests).

Absolutely - I'd welcome (if anyone were to have the physical, emotional and financial resources) a case being brought against the VIPdx owners (and potentially it's agents/senior employees), regarding the mis selling of the XMRV tests. Just to be absolutely clear I have never intimated that a laboratory could have no liability - merely that the train of liability is different in the UK than elsewhere. However while I believe it would be appropriate for the liability of VIPdx to be tested in Court - that liability would be wholly negated if as Jace claims, patients knew the tests were 'experimental'.

IVI